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Wednesday, August 17, 2011

WHO rules may be killing, not saving children in Africa

Two year old Neema Mramba and her twin sister live with their grandmother in a village called Matsangoni in Kilifi.

When Neema awoke at 3 am on Sunday night, she appeared confused. ‘Neema’s head was hot, so I gave her some drugs I had picked up from the dispensary a while ago,’ says Bahati Chengo, Neema’s grandmother.

The fever subsided but Neema started to fit and in a panic, Ms Bahati called her sister who lived nearby. At the first light of day, the women made their way to Matsangoni dispensary. From there, Neema and her grandmother were rushed to the Kilifi District hospital.

By the time Neema arrived at the hospital, she was having difficulty breathing, was drowsy and had a rapid heart rate. Her hands and feet were cold. Neema was in shock. She was immediately put on a slow drip of intravenous fluid as investigations for the likely cause of her illness continued. According to the WHO guidelines, children like Neema should receive fluids by drip very rapidly but a new study, named Feast, suggests that this would be detrimental.

The Fluid Expansion as Supportive Therapy (Feast) clinical trial begun in six sites within the East African region in January 2009 and was stopped in January 2011. Prof. Sarah Kiguli was the chief principal investigator overlooking four sites in Uganda where the study was conducted. These were Mulago National Referral Hospital in Kampala, Mbale and Soroti in Eastern Uganda; and a mission hospital in Lacor, North Uganda.

The Tanzanian team at Tuele hospital in Muheza was lead by Dr George Mtowe while the Kenyan study was headed by Dr Sam Akech. The Kenyan group at the KEMRI Wellcome Trust Programme, Kilifi were also responsible for the management of the whole trial including monitoring and critically reviewing the quality of the conduct of the study.

In most hospitals in Africa, shock is not recognised and children admitted for shock receive fluids by drip slowly in order to replace that which the child would normally have drunk. The Feast study sought to find out whether following the international and WHO guidelines of rapid fluid administration for children in shock would be better than the current practice of slow infusion of fluids.

The study intended to recruit 3,600 children but was stopped prematurely as per advice from the independent data and safety monitoring committee. The committee had analysed the data and found that following the WHO guidelines of treating shock by administering fluids by drip rapidly to children in shock was of no benefit, indeed the results showed that survival was better in the group who did not receive fluid rapidly.

“The results surprised me,” said Prof Kiguli. “This was because the results went against the recommendations of the WHO and the normal practice in wealthy countries. The Feast study had shown that with every 100 children that received fluids rapidly by drip, 3 deaths occurred purely as a result of the treatment.

“Feast was the only a trial that evaluated the speed and volume of fluid given to a sick child. The international practice of rapidly giving fluids to children in shock due to infectious diseases was not backed by evidence from clinical trials,” Dr Akech said.

Neema Mramba was diagnosed with bacterial infection of the blood and treated accordingly. She was among the first few children benefiting from the findings of the Feast trial, unfortunately, she passed away after two days in hospital.

Across Africa, the mortality rate for shock in children ranges from 11 per cent in hospitals with a good system of care to 22 per cent in others. In the Feast trial, out of the children with shock that were treated with fluid drip rapidly, 11 per cent died, while deaths among those that received the fluid drip slowly was down to 7.5 percent.

Although the percentage difference may appear insignificant, the numbers of children affected is that suffer from shock every year is very large.

If we take the case of the current study, about 3,000 children were admitted with shock from only six hospitals in the East African region over two years. If all these children were given fluid rapidly, about 330 children would die, whereas if they had been put on slow infusion of fluids, 225 children would die.

A surplus 105 children would then die as a result of treatment with rapid drip and not as a result of the shock. Bear in mind that one in every 10 children admitted in hospitals across the continent are in shock.

The number of children’s lives that would be saved by changing the way fluids are given to children in shock would greatly reduce the overall mortality rates in most hospitals.

“Clinicians were being trained across various hospitals to identify shock and treat it with rapid infusion of fluids according to the WHO guidelines. This practice was just beginning to catch up so these results are very timely,” said Dr Akech.

Feast underscores the need for African researchers to re-think recommendations based on research carried out outside the continent.

“African children are not different from those in western countries but their circumstances are different. They are exposed to a different profile of illnesses, for example there is hardly any malaria in the countries where a lot of the practice is based on.

The hospitals where most African children go for care may also lack facilities to for example resuscitate children who deteriorate fast and therefore require a more cautious approach in the treatments offered.

The trial illustrates that African clinical researchers need to look again at the diseases that most affect our children, how we manage them and whether the current management practices are the most appropriate,’ Dr Sam Akech said.